BRIEF-SOBI Receives Complete Response Letter From FDA For NASP

- Swedish Orphan Biovitrum AB (publ) SOBIV.ST:

  • SOBI RECEIVES COMPLETE RESPONSE LETTER FROM FDA FOR NASP (NANOENCAPSULATED SIROLIMUS PLUS PEGADRICASE)

  • SWEDISH ORPHAN BIOVITRUM - FDA REQUESTS ADDITIONAL MANUFACTURING DATA AND FACILITY DEFICIENCIES ADDRESSED FOR NASP

  • SWEDISH ORPHAN BIOVITRUM - SOBI TO MEET WITH FDA TO DISCUSS NASP RESUBMISSION

Source text: ID:nWkr8yBKgg

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